Collaborative Observational Study of Myopia in COMET Children 2-Coordinating Ctr

COMET儿童近视的协作观察研究2-协调中心

• 批准号: 7893292
• 负责人: LESLIE G HYMAN
• 金额: $ 6.73万
• 依托单位: STATE UNIVERSITY NEW YORK STONY BROOK
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-01 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7893292
• 关键词: 11 year old; 16 year old; 17 year old; 7 year old; African American; Age; Child; Clinical; Clinical Trials; Cohort Studies; Communication; Contact Lenses; Cornea; Data; Data Analyses; Data Collection; Data Quality; Development; Environmental Risk Factor; Esophoria; Ethnic Origin; Ethnic group; Evaluation; Eye; Genetic; Glass; Growth; Hispanics; Hour; Individual; Intervention; Learning; Length; Literature; Longitudinal Studies; Measurement; Modification; Monitor; Myopia; Observational Study; Occupational; Operative Surgical Procedures; Optical Coherence Tomography; Optometry; Parents; Pathology; Physiologic Intraocular Pressure; Procedures; Process; Protocols documentation; Publications; Refractive Errors; Reporting; Risk; Risk Factors; Role; Subgroup; Testing; Thick; Time; Vision; Work; base; cohort; college; data management; design; ethnic difference; high intraocular pressure; macula; predictive modeling; quality assurance; response

DESCRIPTION (provided by applicant): The Collaborative Observational Study of Myopia in COMET Children (COSMICC) is a longitudinal study that has followed the cohort of children who participated in the Correction of Myopia Evaluation Trial (COMET. Currently, at an average age of 17 years, myopia has stopped progressing in only 42% of the subjects in this cohort. This group of ethnically diverse myopic subjects has 7-8 years of standardized, reliable measurements of refractive error and ocular components, with outstanding retention of 93%. Thus, this cohort provides a unique opportunity to characterize progression and stabilization of myopia and to learn how they are influenced by genetic and environmental factors identified from COMET and from the literature. By studying this cohort for an additional 5 years, COSMICC2 seeks to accomplish the following aims. Aim 1: To use the Gompertz and other functions to characterize the course of myopia in the 58% of the COSMICC cohort with progressing myopia and to develop predictive models based on previously identified, intrinsic risk factors (age, ethnicity, and parental myopia). We expect to find that myopia stabilization determined from Gompertz functions fit to the data will be comparable to stabilization using a clinical definition and that results for axial elongation will be similar to those for myopia progression. Aim 2: To test 4 hypotheses related to environmental risk factors for myopia progression and stabilization in this well-characterized cohort of myopes Aim 3: To test 3 hypotheses related to the association of IOP, CCT, and macular thickness with changes in axial elongation and myopia progression in COSMICC subjects This application seeks continued support for the activities of the Coordinating Center, which has successfully served in this role since COMET began and will remain similar to COSMICC. The major responsibilities of the Coordinating Center are to: 1) provide epidemiologic and biostatistical expertise to the design, conduct and analysis of COSMICC2; 2) develop and implement the statistical analysis plan; 3) collaborate in the development, modification and distribution of forms, documents and protocols; 4) be responsible for data management; processing and analysis; 5) prepare reports to monitor recruitment, data collection, and data quality; 6) coordinate and document communications among clinical centers; 7) be responsible for quality assurance procedures; and 8) collaborate in preparing publications of the results. Additional new aims for COSMICC2 are to process and analyze data concerning new measurements of IOP, CCT and macular thickness and volume as they relate to myopia and axial length. Separate applications have been submitted by the Study Chair and each of the 4 clinical centers.

描述(申请人提供)：彗星儿童近视合作观察研究(COSMICC)是一项纵向研究，跟踪了参与矫正近视评估试验(COMET)的儿童队列。目前，平均年龄为17岁的近视在这一队列中只有42%的受试者停止了近视的发展。这组不同种族的近视受试者有7-8年的屈光不正和眼睛成分的标准化、可靠的测量，突出的保留率为93%。因此，这个队列提供了一个独特的机会来描述近视的进展和稳定，并了解它们是如何受到从彗星和文献中确定的遗传和环境因素的影响。通过对这一群体再研究5年，COSMICC2寻求实现以下目标。目的1：使用Gompertz和其他功能来描述COSMICC队列中58%的进展性近视的近视过程，并基于先前确定的内在危险因素(年龄、种族和父母近视)建立预测模型。我们期望发现，根据符合数据的Gompertz函数确定的近视稳定度将与使用临床定义的稳定度相当，轴向延长的结果将类似于近视进展的结果。目的2：检验4个与近视进展和稳定的环境危险因素有关的假说。目的3：检验3个与眼压、中央角膜厚度和黄斑厚度与COSMICC受试者眼轴延长和近视进展变化相关的假说。本申请寻求对协调中心活动的持续支持，协调中心自Comet诞生以来一直成功地发挥这一作用，并将继续类似于COSMICC。协调中心的主要职责是：1)为COSMICC2的设计、实施和分析提供流行病学和生物统计学专业知识；2)制定和实施统计分析计划；3)协作开发、修改和分发表格、文件和方案；4)负责数据管理；处理和分析；5)编写报告以监测招募、数据收集和数据质量；6)协调和记录临床中心之间的沟通；7)负责质量保证程序；8)协作准备结果出版物。COSMICC2的其他新目标是处理和分析与近视和眼轴长度有关的眼压、CCT和黄斑厚度和体积的新测量数据。研究主席和4个临床中心分别提交了申请。